ILUVIEN® Implant for Diabetic Macular Edema

(NEW DAY Trial)

Recruiting at 38 trial locations

Overseen By Ashley Gantt

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Alimera Sciences

Must not be taking: Steroids, Aflibercept, Ranibizumab, others

Disqualifiers: Proliferative diabetic retinopathy, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, masked, active-controlled, parallel-group, multi-center study that will assess the efficacy of ILUVIEN as a baseline therapy in the treatment of Center Involving DME (CI-DME). The study will enroll patients who are either treatment naïve or have not received any DME treatments for the preceding 12 months as documented in medical records. Patients who received DME treatment \>12 months before screening, must not have received \>4 intravitreal injections. The study will compare 2 treatment regimens: ILUVIEN intravitreal implant (0.19 mg) followed by supplemental aflibercept as needed per protocol criteria (2 mg/0.05 mL), compared to intravitreal aflibercept loading dose (2 mg administered by intravitreal injection every 4 weeks for 5 consecutive doses) followed by supplemental aflibercept as needed per protocol criteria (2 mg/0.05 mL).

Research Team

Samer Kaba, MD

Principal Investigator

Alimera Sciences, Inc.

Eligibility Criteria

This trial is for adults over 18 with early Diabetic Macular Edema (DME) confirmed by SD-OCT and specific vision acuity scores. It's not for those with advanced diabetic eye disease, other causes of macular edema, recent certain eye treatments, or uncontrolled glaucoma.

Inclusion Criteria

My vision in the study eye is somewhat impaired but not severely.

Must have CI-DME confirmed by Spectral Domain Ocular Coherence Tomography (SD-OCT) and Center Subfield Thickness (CST) of: ≥350 µm in the study eye

Exclusion Criteria

I have or had high eye pressure, glaucoma, or a significant eye condition.

Steroid Challenge Exclusion Criterion- At the Baseline Visit, patients who are determined to have an IOP ≥25 mmHg or an increase ≥8 mmHg from Screening will be excluded from the study.

I have not had certain eye treatments in the past year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ILUVIEN intravitreal implant followed by supplemental aflibercept as needed, or intravitreal aflibercept loading dose followed by supplemental aflibercept as needed

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Aflibercept
• Iluvien 0.19 MG Drug Implant

Trial Overview The study compares two DME treatments: an ILUVIEN implant followed by as-needed aflibercept injections versus a series of aflibercept injections alone. The goal is to see if ILUVIEN can be an effective initial treatment.

Participant Groups

Group I: Aflibercept Arm Active Control 1 Intervention

Intravitreal aflibercept

Group II: ILUVIEN Arm Active Control 2 Interventions

Intravitreal ILUVIEN

Who Is Running the Clinical Trial?

Alimera Sciences

Lead Sponsor

Trials

14

Recruited

3,000+